Efficacy and safety of electroacupuncture in acute decompensated heart failure: a study protocol for a randomized, patient- and assessor-blinded, sham controlled trialReportar como inadecuado




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BMC Complementary and Alternative Medicine

, 17:361

Research methodology

Abstract

BackgroundThe purpose of this trial is to evaluate the effectiveness and safety of electroacupuncture in the treatment of acute decompensated heart failure compared with sham electroacupuncture.

MethodsThis protocol is for a randomized, sham controlled, patient- and assessor-blinded, parallel group, single center clinical trial that can overcome the limitations of previous trials examining acupuncture and heart failure. Forty-four acute decompensated heart failure patients admitted to the cardiology ward will be randomly assigned into the electroacupuncture treatment group n = 22 or the sham electroacupuncture control group n = 22. Participants will receive electroacupuncture treatment for 5 days of their hospital stay. The primary outcome of this study is the difference in total diuretic dose between the two groups during hospitalization. On the day of discharge, follow-up heart rate variability, routine blood tests, cardiac biomarkers, high-sensitivity C-reactive protein hs-CRP level, and N-terminal pro b-type natriuretic peptide NT-pro BNP level will be assessed. Four weeks after discharge, hs-CRP, NT-pro BNP, heart failure symptoms, quality of life, and a pattern identification questionnaire will be used for follow-up analysis. Six months after discharge, major cardiac adverse events and cardiac function measured by echocardiography will be assessed. Adverse events will be recorded during every visit.

DiscussionThe result of this clinical trial will offer evidence of the effectiveness and safety of electroacupuncture for acute decompensated heart failure.

Trial registrationClinical Research Information Service: KCT0002249.

KeywordsHeart failure Electroacupuncture Acupuncture Randomized controlled trial AbbreviationsANSAutonomic nervous system

BIBlinding index

BNPB-type natriuretic peptide

EQ-5DEuroQol five dimensions questionnaire

HFHeart failure

HRVHeart rate variability

hs-CRPHigh-sensitivity C-reactive protein

IRBInstitutional review board

KHMCKyung hee medical center

KMDKorean medicine doctor

MACEMajor adverse cardiac event

MLHFQMinnesota living with heart failure questionnaire

NT-pro BNPN-terminal pro b-type natriuretic peptide

NYHANew York heart association

PSDPark sham device

QOLQuality of life

SOPStandard operating procedure

STRICTASTandards for reporting interventions in clinical trials of acupuncture

TEAMTraditional east asian medicine

V1Visit 1

V2Visit 2

V3Visit 3

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Fuente: https://link.springer.com/







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